The multi-faceted agreement will provide for internships for pharmacy students and volunteer teaching by CoreRx Inc. scientists, said Kevin B. Sneed, PharmD, dean of USF’s School of Pharmacy.

“The opportunity for our students to spend time with a firm that is at the front end of prescriptions is invaluable,” Dr. Sneed said. “And it is only the beginning of what will be a varied educational experience for our students, who will ultimately have a keener understanding of the drug-making process. This knowledge will help our graduates take leading roles in managing and delivering technologically-advanced pharmaceutical care in tomorrow’s patient-centered practice. This affiliation also affirms our commitment to create innovative academic-entrepreneurial partnerships.”

“We’re thrilled to offer this affiliation with USF and to offer a hands-on learning opportunity for its pharmacy students,” said Todd R. Daviau, PhD, CEO and co-founder of CoreRx Inc.

“We are excited about the fact that CoreRx will continue to play a role in furthering the development of pharmacy students.”

Among the key concepts pharmacy students will learn through CoreRx Inc. will be the early development stages of pharmaceuticals, how tablets and capsules are made (with hands-on instruction), and the functionality of additional ingredients found in modern-day drugs. In addition, students will learn hands-on processes utilized in the manufacture of a wide range of pharmaceutical dosage forms.

This is not the first time CoreRx Inc. has connected with USF’s education mission. They have hosted USF chemistry students on paid internships for nearly two years.

CoreRx Inc. was founded in 2006 and is a contract pharmaceutical development and manufacturing organization that helps pharmaceutical and biotechnology companies bring new drugs to the clinic quickly and efficiently.

Dr. Sneed championed and was the major architect of the proposal for USF’s four-year Doctor of Pharmacy (PharmD) program, which was approved by the Florida Board of Governors in January 2009. Housed within the USF College of Medicine, the USF School of Pharmacy plans to admit its first class of student in August 2011.

For more information about CoreRx Inc., visit www.corerxpharma.com.

http://blog.pharmtech.com/2010/02/18/industry-should-consider-combination/

Additionally, fixed dose combination products (FDCs) are on the rise. With dwindling pipelines, limited resources, & expiring patents, now, more that ever, combination products are being considered in drug development portfolios. However, regulatory hurdles, physician acceptance, and market strategy, are just a few considerations that one should address. This brief overview will cover specifics regarding fixed dosage combinations (FDC’s), and will hopefully give your company a better understanding to the challenges ahead.  > Read More (PDF)

The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.  more:  http://web.mit.edu/cbi/research/newdigs.html

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

•Aetna
•Bayer Healthcare
•Brookings Institution
•Centers for Disease Control and Prevention (CDC)
•Eli Lilly and Company
•U.S. Food and Drug Administration (FDA)
•Johnson & Johnson
•Medco Health Solutions Inc.
•Pfizer Inc.
•Quintiles Transnational Corp.
•Vertex Pharmaceuticals Inc.
•WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1. share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother waste many millions going down experimental paths that their competitors have already tried and failed.

http://web.mit.edu/cbi/research/newdigs.html

46th DIA Annual Meeting – Washington DC June 13-17, 2010
The DIA Annual Meeting is “the event to attend” each year by biotechnology, pharmaceutical and regulatory professionals. http://www.diahome.org/DIAHOME/FlagshipMeetings/Home.aspx?meetingid=20751

“We are excited at the opportunity to enhance our contract drug development offerings through the Solumer™ technology,” said Todd R. Daviau, CEO of CoreRx. “Since the beginning, CoreRx has been working to meet the increasing formulation development challenges of drug delivery, as well as performance enhancement of our client’s drug products.  As companies continue to outsource development, speed, quality, and innovation become increasingly important to our contract lab offerings.By addressing poor water solubility through the use of the Solumer™ technology, CoreRx will be continue to expedite formulation development and keep customers on the fast-track for early drug development and clinical manufacturing.  Additionally, this nanoparticle drug delivery system will help companies competitively differentiate themselves through IP protection, improve bioavailability, and improve/modify the drug release profile.”

As part of the agreement, SoluBest will provide CoreRx with formulation services and technology in exchange for research revenues for products incorporating or manufactured using Solumer™ technology.

“We are pleased to be able to offer CoreRx’s the use of our platform,” said Dr. Amir Zalcenstein, SoluBest’s head of business development, “the platform’s versatility, quick turnaround times and cost efficacy, coupled with CoreRx’s contract drug development experience are sure to make an effective combination.”

“CoreRx is thrilled to offer a unique nanotechnology delivery platform such as SoluBest’s and are enthusiastic about the potential of the Solumer™ technology,” said Brian R. McMillan, CoreRx’s Director of Formulation Development. “We see potential applications for NDA products, as well as generic formulations. This agreement further strengthens our ability to deliver value for our clients as we continue to develop innovative, differentiated drug products.”

In today’s market, pharmaceutical and biotech companies are being asked to do more…with less.  Diminishing resources, pipelines, competition, and increased regulatory hurdles are forcing us to rethink our strategy. We must work smarter, not harder.

The adage “time is money” is a fact well understood by those in the pharmaceutical industry, where developing a new product can take almost a decade and cost hundreds of millions of dollars. To maximize patent life and remain competitive, small biotech companies, as well as large pharma must avoid costly and time-consuming product development.

In early Phase I cases, many will find themselves choosing to deliver the neat drug substance or API directly e.g. API in a capsule or bottle.  This pathway offers an appealing alternative, as it allows companies to obtain critical clinical trial data before the added expense of formulation development and in particular, excipient compatibility and process optimization experiments.  Saving time and money is the ultimate driver in many cases.  However, one must not overlook the science, possibly resulting in loss of time, as well as additional developmental costs.

In a day and age where critical “go/no-go” and long-term development decisions are based on early success in order to receive follow-on tranches of venture capital financing, it should come as no surprise that limited financial resources are forcing pharmaceutical companies to take shortcuts wherever possible. In other words, decisions regarding the fate of new chemical entities are more often than not, based on the bottom line.

Understanding the dilemma; not wanting to be the “decision bottleneck”, pharmaceutical development teams often implement API in capsule approaches to meet aggressive Phase I clinical study start dates.  To make it an easier decision, expedient & precision equipment have been introduced that can accurately fill hard gelatin capsules or vials with neat drug substance. But has this approach become over-utilized, with aggressive timelines and cost containment overshadowing the science of formulation development?

The fact is, API in capsule/bottle approaches for early clinical studies may defer, but will not eliminate the need to conduct formulation development and process optimization. It is therefore critical to weigh carefully the impact on the overall development plan (as well as the added cost and time) of using neat drug substance filled capsules/vials vs. a formulated product in early studies:

• Neat dosing of drug substance can result in greater total development costs. Since the API in bottle/capsule approach only defers the downstream pharmaceutical development work needed to supply later phase clinical and commercial product, it is additive to the total development costs. The added costs are typically minor when taken in context of a typical development program, but should be recognized as not providing a formulation “free ride” through development.

• Neat dosing of drug substance may result in greater total development time. Because excipients and other downstream manufacturing processes may alter the drugs pharmacokinetics and oral bioavailability, formulation decisions based on neat API in capsule projects may cause decisions to be made that detrimentally affect downstream development. This may lead to added time and the need for additional excipient compatibility studies or additional bioavailability studies during critical downstream development.

• Not all APIs are suitable candidates for neat dosing into capsules. Because of the absence of a tamping mechanism on most API in capsule machines, the actual amount of powder that will fit in a capsule may be limited by the powder’s physical characteristics. In some cases, neat drug substances may require preprocessing to increase density and enable high-dose API in capsule. High-dose capsule filling also poses challenges because of the inability to use material bulk density to accurately predict allowable capsule fill weights. The allowable fill weight in a particular capsule size depends on the materials physical characteristics which may be limited by the instruments filling mechanism.

• Excipient compatibility studies should be done with capsule material anyway. Since excipient compatibility studies should be performed between the API and the capsule material, it only makes sense to begin excipient compatibility studies as early in the process as possible. A carefully designed excipient compatibility matrix should not take any more time on stability than that of API and capsule material(s). Added costs, of course, would be a result of the additional analytical time.

• Not all drugs are suitable candidates for neat dosing of drug substance. Before contemplating an API in bottle/capsule project, it is imperative that physicochemical properties of the drug substance be evaluated. Drugs with inadequate or limited bioavailability may require formulation intervention to achieve adequate bioavailability and/or improve adsorption kinetics. In addition, an increase in drug bioavailability due to formulation can significantly decrease the quantity of drug substance required to supply clinical studies. Since the supply of drug substance can often be rate-limiting in the initiation of early clinical studies, removing this drug substance bottleneck can actually decrease the time requirement to enter larger studies and significantly reduce program costs for drugs with complex and expensive manufacturing processes.

In the world of contract pharmaceutical research & development, success hinges on two things: Quality & Timeliness. More often than not, the two are inextricably connected. However, in the final analysis, the strategic decisions tied to pharmaceutical development become ever more complex as the business, regulatory, and scientific demands escalate. The manufacturing of early clinical supplies by dispensing of neat drug substance into capsules or vials may provide an attractive approach to shorten the time for acquiring essential clinical data. However, the downstream implications for later stage development must be carefully weighed, in light of the total development picture.

Unbelievably, another year is behind us and 2010 lies ahead. This is the time of the year to look back on our accomplishments and make our resolutions for the next year.

This past year has been a mixed blessing. It has been one of the most difficult personally, but rewarding in so many other ways. We saw the addition of several key employees, we added several new key accounts, and most importantly – we “hit one out of the park” at this year’s AAPS meeting. We are getting through these tough times together.

The good news is that the work we’ve done is starting to pay off. There is a lot of reason to be optimistic about 2010. For that, we say Thank You for allowing us to be part of your success.